Endocrine Abstracts

JOINT2794

Introduction: Time-restricted feeding (TRF) has demonstrated metabolic improvements in adults with obesity, although evidence in pediatric populations is limited. The TRansForm study (ClinicalTrials.gov ID: NCT05174871) evaluated the safety and effectiveness of a 2-month TRF intervention in children and adolescents with obesity, focusing on anthropometric, metabolic, and gut microbiome outcomes.

Design: This open-label, parallel-group randomized controlled trial allocated (1:1) participants (ages 8–18, BMI-SDS>2) stratified by gender and age into TRF (late 8-hour feeding window, 6 days/week, plus usual care) or Control groups (usual care only). Primary outcomes included safety and BMI-SDS changes at 2 and 12 months. Secondary outcomes encompassed metabolic parameters and gut microbiome. Analysis was conducted using multiple linear regression, adjusted for sex and pubertal status.

Results: Sixty-five participants completed the intervention, and 53 attended the 12-month follow-up. Baseline characteristics included 54% female, average age 13.8±2.5, 18% prepubertal, and BMI-SDS 3.06±0.64. No major adverse events were documented. Median self-reported adherence was 5±3 days/week, with 50% attaining adherence >80% (≥5 fasting days/week). Males and prepubertal individuals exhibited higher probabilities of high adherence than females and postpubertal (X² P =0.029 and P =0.040, respectively). TRF (n = 32) and Control (n = 33) groups showed similar BMI-SDS improvements at 2 (−0.09±0.16vs−0.07±0.12, respectively) and 12 months (−0.11±0.41vs−0.09±0.38). Regression models with high-adherence participants revealed significant BMI-SDS improvements following TRF compared to controls (−0.24±0.11vs.−0.07±0.12) (Table 1). TRF increased LDL-cholesterol levels at 2 and 12 months while marginally reducing HDL-cholesterol (Table 1). No differences were observed in physical activity or energy intake. Microbiome analysis from TRF participants revealed decreased α-diversity (P <0.05), lower fecal short-chain fatty acids, and increases in potentially pathogenic bacteria, including Yersinia, Escherichia coli, and Salmonella enterica strains.

Conclusions: While TRF may improve BMI-SDS, its potential association with worsening lipid profiles and gut dysbiosis raises safety concerns. These findings highlight the necessity for personalized TRF protocols and rigorous metabolic monitoring for pediatric obesity. Further research is required to determine the long-term impact of TRF on pediatric health, as well as the mechanisms linking feeding windows to microbiome-host interactions.